FDA product code HPA: Frame, Trial, Ophthalmic
HPA is the FDA product code for frame, trial, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1415 and reviewed by the Ophthalmic panel. FDA has cleared 5 510(k) submissions under HPA, from 4 different applicants. The average 510(k) review took 64 days (median 49).
Classification
| Field | Value |
|---|---|
| Device name | Frame, Trial, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.1415 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HPA clearance
Top HPA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ascon Medical Instruments, Ltd. | 2 | 1985-07-31 |
| Woodlyn, Inc. | 1 | 1984-06-01 |
| Michael Onufryk | 1 | 1984-03-27 |
| Medical Equipment Designs, Inc. | 1 | 1982-06-14 |
Most recent HPA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K852548 | Ascon Medical Instruments, Ltd. | ATL 225 MW TRAIL LENS SET | 1985-07-31 | 49 |
| K852126 | Ascon Medical Instruments, Ltd. | ATF 101 TRAIL FRAME | 1985-06-05 | 21 |
| K841768 | Woodlyn, Inc. | WOODLYN LIGHTWEIGHT TRIAL FRAME | 1984-06-01 | 35 |
| K833669 | Michael Onufryk | IMAGE DEFLECTOR | 1984-03-27 | 161 |
| K821084 | Medical Equipment Designs, Inc. | UNIVERSAL TRIAL FRAMEE | 1982-06-14 | 56 |
Recalls for HPA devices
openFDA lists no recalls for product code HPA.
Frequently asked questions
What is FDA product code HPA?
HPA is the FDA product code for frame, trial, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1415 and reviewed by the Ophthalmic panel.
What device class is HPA?
Class I, regulation 21 CFR 886.1415. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HPA?
Across 5 cleared submissions the average was 64 days from receipt to decision (median 49).
Which companies have the most HPA clearances?
Ascon Medical Instruments, Ltd. (2); Woodlyn, Inc. (1); Michael Onufryk (1); Medical Equipment Designs, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HPA
- Run a recall and safety report across every HPA manufacturer
- Watch product code HPA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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